NCT02295332

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers. The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 17, 2014

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs

    Approximately 22 weeks

Secondary Outcomes (2)

  • Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]

    22 weeks

  • Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure

    22 weeks

Study Arms (2)

Cohort A

EXPERIMENTAL
Drug: PlaceboDrug: RG7625

Cohort B

EXPERIMENTAL
Drug: PlaceboDrug: RG7625

Interventions

PlaceboDRUG

Matching oral placebo capsules to RG7625, according to treatment schedule

Cohort ACohort B
RG7625DRUG

oral administration, capsules, single ascending dose according to treatment schedule

Cohort ACohort B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female participants, 18 to 60 years of age, inclusive
  • A body mass index between 18 to 30 kg/m2 inclusive
  • Able to participate and willing to give written informed consent and to comply with the study restrictions

You may not qualify if:

  • Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
  • Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
  • Any significant allergic reaction to drugs
  • Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
  • Women who are pregnant or lactating or of childbearing potential
  • Clinically significant abnormal ECG or other risk factors for QT prolongation
  • Use of prescribed or over the counter medication
  • Inability or unwillingness to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Related Publications (1)

  • Theron M, Bentley D, Nagel S, Manchester M, Gerg M, Schindler T, Silva A, Ecabert B, Teixeira P, Perret C, Reis B. Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S. Front Immunol. 2017 Jul 17;8:806. doi: 10.3389/fimmu.2017.00806. eCollection 2017.

    PMID: 28769925DERIVED

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 20, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

NL(1)